BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTHESIA CIRCUIT

    MDR report key: 5079824 · Received September 16, 2015

    Report

    Report Number
    5079824
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    July 29, 2015
    Report Date
    September 8, 2015
    Manufacturer
    WESTMED, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL ADOLESCENT WAS TRANSPORTED TO THE OPERATING ROOM FOR URGENT SURGERY BY THE ANESTHESIA TEAM, WAS FULLY MONITORED, AND UNDERWENT ANESTHETIC INDUCTION WITH ENDOTRACHEAL INTUBATION. AT A POINT EARLY IN THE CASE, A NEW COMPONENT WAS ADDED TO THE PLASTIC ANESTHETIC BREATHING CIRCUIT BY THE ANESTHESIA TEAM, WHICH WAS NOTED TO PREVENT ANY ANALYSIS OF BREATHED GASES (FRESH GAS O2 AND AIR, VOLATILE AGENT, END TIDAL CARBON DIOXIDE). QUICKLY, THE ADDED COMPONENT WAS REMOVED AND REPLACED, AND GAS ANALYSIS RESUMED USING THE PREVIOUS COMPONENT PIECES. THE DEVICE WAS QUICKLY FOUND TO HAVE A MANUFACTURER DEFECT. A BLOCKAGE OF THE SAMPLE LINE WAS FOUND. IT APPEARED A DROP OF HARDENED MANUFACTURER GLUE OCCLUDED THE SMALL LUMEN WHICH IN THIS CASE WAS CONE SHAPED INTERNALLY RATHER THAN THE NORMAL CYLINDRICAL SHAPE. THE PATIENT'S CONDITION DID NOT CHANGE DURING THE EVENT, BUT WAS A HIGH RISK PATIENT FOR DECOMPENSATION, AND THE GAS ANALYZER IS AN ESSENTIAL PIECE OF MONITORING THE PATIENT SAFELY IN THIS CASE. INTERRUPTION WAS BRIEF, AND NO HARM CAME BUT IT DID REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613997 ANESTHESIA CIRCUIT CAI WESTMED, INC. 04272015T10

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR